Validation Engineer (Contract)
Location: Kalamazoo, MI
Job Requisition: 7554
Hourly Pay Range: $50 – $55. Individual rates are based on education, geographic location, and alignment to the market data.
Description for Validation Engineer:
Seeking a Validation Engineer for a contract engagement supporting validation activities within a contract manufacturing environment serving the medical device industry. The ideal candidate has hands-on experience performing process and equipment validation in a highly regulated environment and is comfortable working directly on the manufacturing floor. This role requires strong technical writing skills, experience authoring and executing validation protocols, and the ability to contribute effectively within a small, collaborative team.
Responsibilities for Validation Engineer:
- Perform process validation and equipment validation activities in a regulated manufacturing environment.
- Write, execute, and document IQ/OQ/PQ validation protocols.
- Operate equipment directly to support validation testing and execution.
- Prepare and maintain validation documentation in compliance with quality system requirements.
- Conduct validation activities in alignment with QMS standards, ideally ISO 13485.
- Support and collaborate with manufacturing, quality, and engineering teams to resolve validation issues.
- Participate in risk management activities; PFMEA experience is a plus.
- Assist with validation activities related to wet-to-dry processes (preferred).
- Support validation for direct converting operations (preferred).
- Apply basic lean manufacturing principles to improve processes and workflows.
- Communicate effectively with cross-functional team members, providing updates, findings, and documentation.
- Ensure validation activities align with company core values and team culture expectations.
Requirements for Validation Engineer:
- Bachelor’s degree in Engineering; Mechanical Engineering preferred, but Electrical or Chemical Engineering degrees are also suitable.
- Hands-on experience with process and equipment validation.
- Must have performed validation work in a highly regulated industry; medical device experience strongly preferred.
- Experience with IQ/OQ/PQ protocol writing and execution.
- Strong understanding of Quality Management Systems (QMS); ISO 13485 experience highly preferred.
- Comfortable spending significant time on the manufacturing floor performing hands-on validation tasks.
- Strong technical writing and communication skills.
- Demonstrated ability to work effectively in a small team environment.
Preferred / Nice-to-Have Experience:
- Experience with wet-to-dry processes.
- Experience in direct converting operations.
- PFMEA or broader risk management experience.
- Exposure to lean manufacturing practices.
Benefits for Validation Engineer:
- Health insurance eligibility on 1st day of employment (Medical, Dental)
- 401k after 6 months of employment
- Accrued Paid Time Off
